Mandatory requirements for pediatric drug development in the EU and the US for novel drugs—A comparative study

por Christiansen, Helle, De Bruin, Marie L., Hallgreen, Christine E.
Publicado 2022

Epidemiology of Adverse Drug Reactions in Europe: A Review of Recent Observational Studies

por Bouvy, Jacoline C., De Bruin, Marie L., Koopmanschap, Marc A.
Publicado 2015

Pharmacogenetic‐Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017

por Maliepaard, Marc, Toiviainen, Timi, De Bruin, Marie L., Meulendijks, Didier
Publicado 2020

Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers

por Klein, Kevin, De Bruin, Marie L., Broekmans, Andre W., Stolk, Pieter
Publicado 2015

Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US

por Christiansen, Helle, De Bruin, Marie L., Frokjaer, Sven, Hallgreen, Christine E.
Publicado 2022

Resting Heart Rate Is a Risk Factor for Mortality in Chronic Obstructive Pulmonary Disease, but Not for Exacerbations or Pneumonia

por Warnier, Miriam J., Rutten, Frans H., de Boer, Anthonius, Hoes, Arno W., De Bruin, Marie L.
Publicado 2014

Evidence Synthesis in Harm Assessment of Medicines Using the Example of Rosiglitazone and Myocardial Infarction

por Rietbergen, Charlotte, Stefansdottir, Gudrun, Leufkens, Hubert G., Knol, Mirjam J., De Bruin, Marie L., Klugkist, Irene
Publicado 2018

Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile

por Wang, Ting, McAuslane, Neil, Goettsch, Wim G., Leufkens, Hubert G. M., De Bruin, Marie L.
Publicado 2022

Risk of bladder cancer in patients with diabetes: a retrospective cohort study

por Goossens, Maria E, Zeegers, Maurice P, Bazelier, Marloes T, De Bruin, Marie L, Buntinx, Frank, de Vries, Frank
Publicado 2015

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

por Essink, Sharon C. M., Zomerdijk, Inge M., Straus, Sabine M. J. M., Gardarsdottir, Helga, De Bruin, Marie L.
Publicado 2023

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

por Duijnhoven, Ruben G., Straus, Sabine M. J. M., Raine, June M., de Boer, Anthonius, Hoes, Arno W., De Bruin, Marie L.
Publicado 2013

Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports

por Klein, Kevin, Scholl, Joep H. G., Vermeer, Niels S., Broekmans, André W., Van Puijenbroek, Eugène P., De Bruin, Marie L., Stolk, Pieter
Publicado 2015

An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe

por Ebbers, Hans C., Langedijk, Joris, Bouvy, Jacoline C., Hoekman, Jarno, Boon, Wouter P. C., de Jong, Jean Philippe, De Bruin, Marie L.
Publicado 2015

Calcium channel blockers and cancer: a risk analysis using the UK Clinical Practice Research Datalink (CPRD)

por Grimaldi-Bensouda, Lamiae, Klungel, Olaf, Kurz, Xavier, de Groot, Mark C H, Maciel Afonso, Ana S, de Bruin, Marie L, Reynolds, Robert, Rossignol, Michel
Publicado 2016

Data management and data analysis techniques in pharmacoepidemiological studies using a pre‐planned multi‐database approach: a systematic literature review

por Bazelier, Marloes T., Eriksson, Irene, de Vries, Frank, Schmidt, Marjanka K., Raitanen, Jani, Haukka, Jari, Starup‐Linde, Jakob, De Bruin, Marie L., Andersen, Morten
Publicado 2015

Use of Metformin and Survival of Diabetic Women with Breast Cancer

por Peeters, Paul J.H.L., Bazelier, Marloes T., Vestergaard, Peter, Leufkens, Hubert G.M., Schmidt, Marjanka K., de Vries, Frank, de Bruin, Marie L.
Publicado 2013

Insulin glargine use and breast cancer risk: Associations with cumulative exposure

por Peeters, Paul J. H. L., Bazelier, Marloes T., Leufkens, Hubert G. M., Auvinen, Anssi, van Staa, Tjeerd P., de Vries, Frank, De Bruin, Marie L.
Publicado 2016

Diabetes and Breast Cancer Subtypes

por Bronsveld, Heleen K., Jensen, Vibeke, Vahl, Pernille, De Bruin, Marie L., Cornelissen, Sten, Sanders, Joyce, Auvinen, Anssi, Haukka, Jari, Andersen, Morten, Vestergaard, Peter, Schmidt, Marjanka K.
Publicado 2017

The association of diabetes mellitus and insulin treatment with expression of insulin-related proteins in breast tumors

por Bronsveld, Heleen K., De Bruin, Marie L., Wesseling, Jelle, Sanders, Joyce, Hofland, Ingrid, Jensen, Vibeke, Bazelier, Marloes T., ter Braak, Bas, de Boer, Anthonius, Vestergaard, Peter, Schmidt, Marjanka K.
Publicado 2018

Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study

por But, Anna, De Bruin, Marie L., Bazelier, Marloes T., Hjellvik, Vidar, Andersen, Morten, Auvinen, Anssi, Starup-Linde, Jakob, Schmidt, Marjanka K., Furu, Kari, de Vries, Frank, Karlstad, Øystein, Ekström, Nils, Haukka, Jari
Publicado 2017